unit 2: republic act 4688

Republic Act 4688

* **Clinical Laboratory Law**
* Comprised of eight (8) sections only
* Approved on **June 18, 1966**

Section 1

Any **person, firm or corporation, operating and maintaining a clinical laboratory** in which body fluids, tissues, secretions, excretions and radioactivity from humans or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, **shall register and secure a license** __**annually**__ **at the office of the Secretary of Health**

government hospital laboratories doing routine or minimum laboratory examinations

**Section 1:**

shall be **exempt** from the provisions of this section if their services are extensions of government regional or central laboratories

**Section 2**

It shall be **unlawful** for __any person to be professionally in-charge of a registered clinical laboratory__ unless **he is a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health**, such authorization to be **renewed annually**

such laboratory is under the administration, direction and **supervision of an** __**authorized physician**__

**Section 2:**

**No license shall be granted or renewed** by the Secretary of Health for the operation and maintenance of a clinical laboratory unless

**Section 3**

The **Secretary of Health**, through the Bureau of Research and Laboratories shall be charged with the **responsibility of strictly enforcing the provisions** of this Act and **shall be authorized to issue such rules and regulations** as may be necessary to carry out its provisions

Section 4

Any person, firm or corporation who **violates** any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health **shall be punished**

not less than **one month** but not more than **one year**

**Section 4:**

imprisonment

not less than **one thousand pesos** nor more than **five thousand pesos**

**Section 4:**

fine

**Section 5:** Separability clause

If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be **invalid**, the judgment shall not affect, impair, or invalidate the remainder thereof

fifty thousand pesos

**Section 6:**

The sum of ___, or so must thereof as may be necessary, is hereby authorized to be **appropriated**, out of any funds in the National Treasury

**Section 7:** Repealing clause

All Acts or parts of Acts which are **inconsistent** with the provisions of this Act are hereby repealed.

**Executive Order No. 102, Series of 1999**

Redirecting the Functions & Operations of DOH

Administrative Order No. **59**, Series of **2001**

Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines

Administrative Order No. **2007-00**__**27**__

**Revised** Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines

Administrative Order No. **2008-000**__**2**__

**Posting of Schedule of Fees** for Laboratory and Other Diagnostic Services of Hospitals and other Health Facilities

Administrative Order No. **2008-000**__**7**__

**Schedule of Fees** for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories

Administrative order No. **2021-00**__**37**__

**New** Rules and Regulation Governing the Regulation of Clinical Laboratories in the Philippines

**Health Facilities and Service Regulatory Bureau** (HFSRB)

* specific department of DOH in-charge of **licensing and regulation of all health facilities** including Clinical Laboratories
* formerly BHFS (Bureau of Health Facilities & Services)

Applicant

**Definition of Terms:**

natural or juridical **person** who intends to operate a clinical laboratory

CHD

**Definition of Terms:**

Center for Health Development

Clinical Laboratory

**Definition of Terms:**

**facility** where tests are done on specimens from human body to obtain information about health status of patient for prevention, diagnosis and treatment of diseases

Critical Values

**Definition of Terms:**

panic values originally described by Lundberg as "**life-threatening**" unless something is done promptly and for which some corrective action could be undertaken

EQAP

**Definition of Terms:**

**External Quality Assessment Program**; program where participating laboratories are **given unknown samples** for analysis

Assessment Tool

**Definition of Terms:**

**checklist** used by regulatory officers **during inspection visits** to evaluate compliance of clinical laboratory to minimum standards and technical requirements

AO 2021-0037 **Annex B1**

**Definition of Terms:**

**ASSESSMENT TOOL** FOR LICENSING A GENERAL CLINICAL LABORATORY

AO 2021-0037 **Annex B2**

**Definition of Terms:**

**EQUIPMENT**/INSTRUMENT S/GLASSWARE/SUPPLIES/ REAGENTS **PER AREA OF ACTIVITY**/SERVICE CAPABILITY OF GENERAL CLINICAL LABORATORY

AO 2021-0037 **Annex C**

**Definition of Terms:**

**PROHIBITED ACTS** IN THE OPERATIONS OF CLINICAL LABORATORIES

AO 2021-0037 **Annex D1**

**Definition of Terms:**

PLANNING AND DESIGN **GUIDELINES** FOR GENERAL CLINICAL LABORATORY

AO 2021-0037 **Annex D2**

**Definition of Terms:**

**CHECKLIST FOR REVIEW OF FLOOR PLANS** GENERAL CLINICAL LABORATORY

AO 2021-0037 **Annex E**

**Definition of Terms:**

GUIDELINES IN SECURING FOR **REMOTE COLLECTION** PERMIT FOR CLINICAL LABORATORIES

AO 2021-0037 **Annex F**

**Definition of Terms:**

**APPLICATION FORM FOR CERTIFICATE** OF REGISTRATION FOR RESEARCH AND TEACHING CLINICAL LABORATORY

Institution

**Definition of Terms:**

corporate body or **establishment** organized for an **educational, medical, charitable or similar purpose**

License

**Definition of Terms:**

**issued by DOH** to an individual, agency, partnership or corporation **that operates a clinical laboratory** upon compliance with the requirements set forth

Licensee

**Definition of Terms:**

individual, agency, partnership or corporation to whom the **license is issued and upon whom rests compliance**

Mobile Clinical Laboratory

**Definition of Terms:**

**laboratory testing unit that moves from testing site to another testing site**, or has a **temporary** testing location; shall have a __base laboratory__

Monitoring Examinations

**Definition of Terms:**

tests **done in series on patients** as a guide for treatment or follow-up of their condition

NRL (**National Reference Laboratory**)

**Definition of Terms:**

laboratory in a government hospital designated by DOH **to provide special functions and services for** __**specific**__ **disease areas**

POL (**Physician’s Office Laboratory**)

**Definition of Terms:**

individual doctor's office/ **clinic** wherein laboratory examinations are performed

POCT (**Point of Care Testing**)

**Definition of Terms:**

**diagnostic testing at or near the site of patient care** rather than in clinical laboratory; includes bedside testing, outpatient and home care

Routine Tests

**Definition of Terms:**

**basic, commonly requested tests** in the laboratory, the results of which are not required to be released immediately upon completion

Satellite Testing Site

**Definition of Terms:**

any testing site that **performs laboratory examinations** __under the administrative control of a licensed laboratory__, but **performed outside the physical confines** of that laboratory

STAT Tests

**Definition of Terms:**

done on **urgent cases**, results of which shall be released immediately, within **one (1) hour after the procedure.**

Regulations, Licensing, and Enforcement Division (RLED)

**Definition of Terms:**

A division at the Center for Health Development (CHD) **responsible for the issuance** of Certificate of Need, Permit to Construct, License to Operate/Authority to Operate, and the **conduct monitoring of hospital and health facilities**

Permit to Construct

**Definition of Terms:**

a **permit** issued by DOH to an **applicant who will establish and operate** a hospital or other health facility, upon compliance with required documents; **required for hospitals and other health facilities** with __substantial alteration, expansion, renovation, or for additional services (add-ons)__ beyond their service capability

Initial Application

**Definition of Terms:**

refer to **applications by newly constructed health facilities**, or those **with changes in the circumstances of the facility**, such as, but not limited to, change of ownership, transfer of site, increase in beds or for additional services beyond their service capability and major alterations or renovation

**National External Quality Assessment Scheme** (NEQAS)

**Definition of Terms:**

an **EQAP activity** conducted by the National Reference Laboratories to **assess the quality of performance and accuracy of the results** of laboratories.

Referral Tests

**Definition of Terms:**

refers to **CL tests that are either sent-out or outsourced to other DOH-licensed CL** with the same or higher service capability.

**National Kidney and Transplant Institute** (NKTI)

**National Reference Laboratories:**

* Hematology
* Immunohematology
* Urinalysis

**STD/AIDS Central Cooperative Laboratory** (SACCL)

**National Reference Laboratories:**

* Serology

**Lung Center of the Philippines** (LCP)

**National Reference Laboratories:**

* Clinical Chemistry

**East Avenue Medical Center** (EAMC)

**National Reference Laboratories:**

* Drug Testing
* Water Microbiology
* Micronutrient Assay

**Research Institute of Tropical Medicine** (RITM)

**National Reference Laboratories:**

* Microbiology
* Parasitology

Government

**Classification of Laboratories:** *By Ownership*

operated and maintained, partially or wholly, **by the national government, a local government unit** (provincial, city or municipal), any other political unit or any department, division, board or agency thereof

Private

**Classification of Laboratories:** *By Ownership*

**privately owned**, established and operated with funds through donation, principal, investment or other means, by any individual, corporation, association or organization

**Clinical** Pathology

**Classification of Laboratories:** *By Function*

* deals with the **chemical and cellular analyses of blood and other body fluids**
* Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology and Therapeutic Drug Monitoring

**Anatomical** Pathology

**Classification of Laboratories:** *By Function*

* provides **processing and examination of surgical specimens as to the physical appearance and microscopic structure of tissues**
* Surgical Pathology, lmmunohistopathology, Cytology, Autopsy, Forensic Pathology and Molecular Pathology

**Molecular** Pathology

**Classification of Laboratories:** *By Function*

* deals with the **analysis of certain genes, proteins and other molecules** in samples from organs, tissues or bodily fluids in order to diagnose disease

Institution-based

**Classification of Laboratories:** *By Institutional Character*

* a laboratory that operates **within the premises** and as part of an institution, such as but not limited to hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center
* A laboratory that is located **within the premises** and operates as part of a **DOH licensed health facility.**

Free-standing/Non-institutional based

**Classification of Laboratories:** *By Institutional Character*

* a laboratory that does not form part of any other institution
* A laboratory that operates **independently** and is not attached to any DOH licensed health facility.

Primary

**(AO 2007-0027) Classification of Laboratories:** *By Service Capability:* __*General CL*__

* Routine Hematology
* Complete Blood Count
* Hemoglobin
* Hematocrit
* WBC Count
* WBC Differential Count
* **Qualitative** Platelet Determination
* Routine Urinalysis
* Routine Fecalysis
* Blood Typing (hospital based)

* Clinical Microscopy
* Clinical Chemistry
* Serology/Immunology
* Microbiology

**AO 2021-0037:**

Primary Laboratory additions

Secondary

**(AO 2007-0027) Classification of Laboratories:** *By Service Capability:* __*General CL*__

* Routine Clinical Chemistry
* Glucose
* Blood Urea Nitrogen
* Uric Acid
* Creatinine
* Total Cholesterol
* **Quantitative** Platelet Determination
* Cross Matching (hospital based)
* Gram Staining (hospital based)
* KOH (hospital based)

Tertiary

**(AO 2007-0027) Classification of Laboratories:** *By Service Capability:* __*General CL*__

* Special Chemistry
* Special Hematology, including coagulation procedures
* Immunology
* Microbiology
* Culture & Sensitivity
* Aerobic & Anaerobic (for hospital based)
* Aerobic or Anaerobic (for non-hospital based)

Limited Service Capability

**Classification of Laboratories:** *By Service Capability:* __*General CL*__

Provides laboratory **tests required for a particular service** in institutions such as but not limited to dialysis centers and social hygiene clinics

Clinical Laboratory for **Anatomic Pathology**

**Classification of Laboratories:** *By Service Capability:* __*General CL*__

provides services for any of the following, but not limited to: **cytology and histopathology**

Clinical Laboratory for **Molecular Pathology**

**Classification of Laboratories:** *By Service Capability:* __*General CL*__

provides services for **genetics, immuno/hematopathology and infectious disease**. COVID-19 testing laboratories shall be covered by another order.

Clinical laboratories **exclusive for research and teaching purposes**

**General Guidelines:**

shall be **exempted** from the licensing requirement but shall be required to register

* **Assisted Reproduction** Technology
* **Molecular & Cellular** Technology
* **Molecular Biology**
* **Molecular** Pathology
* **Forensic** Pathology
* **Anatomic** Pathology

**General Guidelines:** *Special Laboratories*

**license of clinical laboratory** of the hospital

**General Guidelines:**

**NRL** shall be covered by ___

required

**General Guidelines:**

**POL** ___ to secure a LTO

management of clinical laboratory

**General Guidelines:**

POCT (in hospital) required under ___

Pathologist

**Specific Guidelines:** *Human Resources*

* **Head** of Laboratory
* shall have **administrative and technical supervision** of the activities in the laboratory

**workload and service**s being provided

**Specific Guidelines:** *Human Resources*

* number of staff shall depend on ___

Rotation 24-hour duty

**Specific Guidelines:** *Human Resources*

Microscopy, Hematology, Clinical chemistry

minimum of 8, maximum of 12

**Specific Guidelines:** *Human Resources*

Working hours

50 tests

**Specific Guidelines:** *Human Resources*

Manual testing: 8 hours

75 tests

**Specific Guidelines:** *Human Resources*

Manual testing: 12 hours

100 tests

**Specific Guidelines:** *Human Resources*

Automated testing: 8 hours

150 tests

**Specific Guidelines:** *Human Resources*

Automated testing: 12 hours

10 sq m

**Specific Guidelines:** *Physical Facilities:* __*Minimum Technical Working Area*__

Primary

20 sq m

**Specific Guidelines:** *Physical Facilities:* __*Minimum Technical Working Area*__

Secondary

60 sq m

**Specific Guidelines:** *Physical Facilities:* __*Minimum Technical Working Area*__

Tertiary

Satisfactory performance rating

**Specific Guidelines:** *Physical Facilities:* __*Quality Control Program*__

criteria for **renewal of license**

Refusal to participate in EQAS-NRL

**Specific Guidelines:** *Physical Facilities:* __*Quality Control Program*__

basis for **suspension/revocation of license**

Reporting

**Specific Guidelines:** *Physical Facilities*

* Bear the **name and signature of Pathologist & RMT**
* **No report orally or in writing without directive from pathologist** or associate except in emergency cases

Recording

**Specific Guidelines:** *Physical Facilities*

* All requests and reports of all specimens **submitted and examined**
* Kept in file for **at least 1 year**

kept permanently

**Specific Guidelines:** *Physical Facilities:* __*Recording*__

Anatomic and forensic pathology reports

**One-Stop-Shop** Licensure System

**Renewal of LTO:**

Hospitals

first day of October to last day of November

**Renewal of LTO:**

Non-hospitals: **discount** on renewal fee if application completed during this period

5 working days

**Renewal of LTO:**

processed not later than ___ after expiration date of LTO

automatically **cancelled without notice**

**Renewal of LTO:**

LTO ___ when failure to submit a duly accomplished application form and to pay proper fee on or before the expiration date stated in license

accessibility of premises and facilities for inspection

**Inspection**:

Licensee shall ensure ___ of CHD Director or authorized representative(s) at any reasonable time

availability of all pertinent records for checking/review

**Inspection**:

Licensee shall ensure ___ of CHD Director or his authorized representative(s)

Refusal

**Violations:**

___ on any clinical lab to participate in EQAP

Issuance of a report, orally or in writing

**Violations:**

___ (in whole or part thereof) which is not in accordance with documented procedures

perform technical procedures

**Violations:**

Permitting **unauthorized persons** to ___

Deviations

**Violations:**

___ from standard test procedure

unlicensed laboratory

**Violations:**

Lending or using the name of licensed laboratory or head or RMT to an ___

secure LTO

**Violations:**

**Unauthorized use of the name and signature of Pathologist and RMT** to ___